• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PCO12
Device Problems Entrapment of Device (1212); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Anemia (1706); Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Pain (1994); Tachycardia (2095); Discharge (2225); Hernia (2240); Injury (2348); Blood Loss (2597); Fluid Discharge (2686); No Code Available (3191); Constipation (3274); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The patient underwent a repair of recurrent incisional hernia, open repair of left inguinal hernia, and implantation of mesh as part of repair of recurrent incisional hernia. He had revision surgery 8 years and 2 months post-surgery. The patient experienced surgical revision.
 
Event Description
The patient's attorney alleged a deficiency against the device. Product was used for therapeutic treatment of an incisional hernia and a left inguinal hernia. It was reported that after implant, the patient experienced recurrence, dense adhesions, sutures pulled through, postoperative bleeding, hypotension, and areas of oozing. Post-operative patient treatment includes multiple revision surgeries, repair of hernia with mesh, open component separation reconstruction of abdominal wall, adhesions taken off previous repairs.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic.  the fda was notified of this large complaint receipt.  due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. (outcome attributed to adverse event remove: other). If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The patient's attorney alleged a deficiency against the device. Product was used for therapeutic treatment of an incisional hernia and a left inguinal hernia. It was reported that after implant, the patient experienced recurrence, dense adhesions, sutures pulled through, postoperative bleeding, hypotension, areas of oozing, pain, constipation, tachycardia, anemia, and blood clots in the abdomen. Post-operative patient treatment includes multiple revision surgeries, repair of hernia with mesh, open component separation reconstruction of abdominal wall, adhesions taken off previous repairs.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
tracy landers
5920 longbow drive
boulder,co, CT 80301
3035816943
MDR Report Key7448315
MDR Text Key106135439
Report Number9615742-2018-00927
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040998
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 12/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/30/2012
Device Model NumberPCO12
Device Catalogue NumberPCO12
Device Lot NumberPHD00258
Was Device Available for Evaluation? No
Date Manufacturer Received12/01/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/20/2018 Patient Sequence Number: 1
-
-